Orange Book product · Brand (NDA)
DUREZOL
DIFLUPREDNATE
At a glance
Jun 23, 2008
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 23, 2008
18 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
DIFLUPREDNATE
Strength
0.05%
Dosage form
EMULSION
Route
OPHTHALMIC
TE code
AB
Application
NDA 022212
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2026DIFLUPREDNATEGeneric (ANDA)
ANDA 213774 · ALEMBIC
- 2025DIFLUPREDNATEGeneric (ANDA)
ANDA 212566 · MYLAN LABS LTD
- 2025DIFLUPREDNATEGeneric (ANDA)
ANDA 218191 · UPSHER SMITH LABS
- 2024DIFLUPREDNATEGeneric (ANDA)
ANDA 219441 · CAPLIN
- 2024DIFLUPREDNATEGeneric (ANDA)
ANDA 207284 · EPIC PHARMA LLC
- 2022DIFLUPREDNATEGeneric (ANDA)
ANDA 214894 · DR REDDYS
- 2021DIFLUPREDNATEGeneric (ANDA)
ANDA 211526 · AMNEAL
- 2021DIFLUPREDNATEGeneric (ANDA)
ANDA 211776 · CIPLA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
